None listed
Conditions
Interventions
Intervention1: Vatika Mens Naturals Anti-Dandruff with Cooling Hair Cream: Route of Administration: Topical Application
Mode of Usage:
For Pre-Treatment and Styling, Massage cream into dry hair from r
Sponsors
Dabur International, UAE
Eligibility
Inclusion criteria
Inclusion criteria: 1) Age: 18-55 years at the time of consent. 2) Sex: Healthy males, non-pregnant and non-lactating females. 3) Females of childbearing potential must have a self-reported negative pregnancy test. 4) Subjects are generally in good health. 5) Subjects have unwashed and untreated scalp for 2 days. 6) Subject exhibiting mild to moderate dandruff status as per ASFS at screening. 7) Subjects are willing to give written informed consent and are willing to follow the study procedure. 8) Subjects who commit not to use medicated or prescription shampoos or hair care products (containing Minoxidil or Anti-hair fall agents) or any other hair growth, hair fall treatment, or hair products other than the test product for the entire duration of the study. 9) Willing to use test product throughout the study period.
Exclusion criteria
Exclusion criteria: 1) History of any dermatological condition of the scalp other than hair loss or dandruff. 2) History of alcohol or drug addiction. 3) Subjects using other marketed dandruff control or hair growth products during the study period. 4) Subjects who have plans of shaving scalp hair during the study. 5) Subjects who are on chronic oral steroids 03 months before initial application and during the study period. 6) History or present condition of irritated or visibly inflamed scalp or severe scalp disease. 7) Subjects having a history or present condition of an allergic response to any cosmetic products. 8) Any other condition which could warrant exclusion from the study, as per the dermatologist’s or investigator’s discretion. 9) Pregnant or breastfeeding or planning to become pregnant during the study period. 10) History of chronic illness which may influence the cutaneous state. 11) Subjects participating in other similar cosmetics, devices or therapeutic trials or hair or scalp care products within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To assess the effectiveness of the test products usage in terms of change in Adherent Scalp Flaking Score using Adherent Scalp Flaking Score by Dermatologist and Dermatologist Trained Evaluator. 2. To assess the effectiveness of the test products in terms of change in scalp dandruff using CASLite Nova. 3. To assess the effectiveness of the test products in terms of change in scalp temperature using thermometer by trained staff.Timepoint: 1. From Day 01 baseline before usage of test products to after usage at T60 mins, after 48 hours of application on Day 03, Day 14, Day 16. 2. From Day 01 baseline before usage of test products to after usage at T60 mins, after 48 hours of application on Day 03, Day 14, Day 16. 3. From Day 01 baseline before usage of test products and immediately after usage on wet hair at T30 min, T60 min and 2 hrs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of test products will be evaluated in terms adverse event and serious adverse event.Timepoint: After usage of test products;To assess the effectiveness of the test products in terms of change in scalp appearance i.e. itchiness, redness, roughness, scaliness by Dermatologist and dermatologist trained evaluator.Timepoint: From Day 01 baseline before usage of test products and after usage at T60 mins, after 48 hours of application on day 03, Day 14, and Day 16.;To assess the effectiveness of the test products in terms of change in scalp itchiness using VAS scale by Dermatologist and Dermatologist Trained Evaluator.Timepoint: From Day 01 baseline before usage of test products and after usage at T60 mins, after 48 hours of application on day 03, Day 14, Day 16.;To assess the effectiveness of the test products in terms of product perception - fights with dandruff, provide clean hair, reduces itching, provide clean and fresh scalp, help hair feel soft and smooth, does not make the scalp dry by using 9-pont hedonic scale.Timepoint: From Day 01 baseline before usage of test products and after usage at T60 mins, after 48 hours of application on Day 03, Day 14, and Day 16. | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed